Land: Storbritannien
Språk: engelska
Källa: HMA (Heads of Medicines Agencies)
florfenicol 0 .
Zoetis UK Ltd
QJ01BA90
Granules for oral solution
florfenicol
Pigs
2013-05-29
Issued: June 2013 AN: 02085/2011 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT COLFEN 200 SP, 200 mg/g granules for use in drinking water for pigs. (Denmark: Colfen SP) (Spain: COLFEN 200, 200 mg/g granules for use in drinking water for pigs) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each g contains: ACTIVE SUBSTANCE: Florfenicol 200.0 mg EXCIPIENT(S): Butylhydroxytoluene (E321) 1.0 mg For a full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Granules for use in drinking water. White to cream waxy granules. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Pigs 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the treatment of swine respiratory disease associated with _Pasteurella _ _multocida_ susceptible to florfenicol. 4.3 CONTRAINDICATIONS Do not administer to boars intended for breeding purposes. Do not administer in cases of previous allergic reactions to florfenicol or any of the excipients. Do not use in piglets less than 6 weeks old. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES If there is no significant improvement after 3 days of treatment, the diagnosis should be reviewed and if necessary the treatment should be changed_._ Issued: June 2013 AN: 02085/2011 Page 2 of 6 4.5 SPECIAL PRECAUTIONS FOR USE i) Special precautions for use in animals The veterinary medicinal product should be used in conjunction with susceptibility testing. Official, national and regional antimicrobial policies should be taken into account when the product is used. Läs hela dokumentet